Suzan Onel

Suzan Onel

K&L Gates LLP

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Latest Posts › FDA


FDA's Evolving Policy Toward Health IT, Medical Apps, and Low Risk Devices

Between January 20 and February 9, 2015, the U.S. Food and Drug Administration (“FDA”) issued four guidances related to its policies toward low risk devices. These guidances were largely developed as an outgrowth from FDA’s...more

3/12/2015 - FDA FDASIA Healthcare Medical Device Accessories Medical Devices Mobile Apps New Guidance Popular

Global Food, Drugs, Medical Devices and Cosmetics Newsletter

Welcome - We are pleased to provide you with the Spring edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. As stated in our inaugural issue, this newsletter provides updates on important...more

4/9/2014 - Australia China Dietary Supplements EU FDA FDCA Food Labeling Food Safety Generic Drugs Medical Devices Nutritional Supplements Prescription Drugs

Off-Label Marketing Questioned as a Viable Criminal Theory – But Stay Tuned

On December 3, 2012, a divided Second Circuit held in United States v. Caronia (“Caronia”) that the misbranding provisions of the Federal Food, Drug, and Cosmetic Act (“FDCA”) do not criminalize “the truthful off-label...more

12/17/2012 - FDA FDCA First Amendment Marketing Misbranding Off-Label Promotion Off-Label Use Pharmaceutical

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